Mesoblast shares climb on licence resubmission to FDA
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The news: The US Food and Drug Administration (FDA) has accepted Mesoblast's Biologics Licence Application (BLA) resubmission for Ryoncil in the treatment of children that have a potentially deadly rash after receiving a bone marrow transplant.
The numbers: Steroid-refractory acute graft versus host diseases (SR-aGVHD)) occurs in approximately 50% of patients who receive an allogeneic bone marrow transplant (BMT). Over 30,000 patients worldwide undergo an allogeneic BMT annually, primarily during treatment for blood cancers, including about 20% in pediatric patients.
SR-aGVHD is associated with mortality as high as 90% and significant extended hospital stay costs. There are currently no FDA-approved treatments in the US for children under 12 with SR-aGVHD.
A decision on the licence is expected on or before 7 January 2025.
Mesoblast's shares lifted 6.9% to $1.24 by 2:50pm AEST.
The context: The ASX- and NYSE-listed Mesoblast said that if approved Ryoncil will be the first allogeneic 'off-the-shelf' cellular medicine in the US, and the first cell therapy for children up to 18 years old with SR-aGVHD.
What they said: Mesoblast CEO Silviu Itescu said: "We are pleased that FDA has accepted our BLA resubmission for review, and look forward to the potential approval for Ryoncil for children with SR-aGVHD".
The source: ASX announcement
